Class 2 Device Recall HardyCHROM MRSA

• Date Initiated by Firm: July 09, 2015
• Date Posted: August 26, 2015
• Recall Status: Terminated on November 10, 2015
• Recall Number: Z-2463-2015
• Recall Event ID: 71804
• 510(K)Number: K102922
• Product Classification: Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
• Product: HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
• Code Information: Cat no. G307 Lot no. H15155
• Recalling Firm/ Manufacturer: Hardy Diagnostics; 1430 W Mccoy Ln; Santa Maria CA 93455-1005
• For Additional Information Contact: Technical Services Department; 800-266-2222 Ext. 2
• Manufacturer Reason for Recall: Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.
• Quantity in Commerce: 2,820 (282 pk/10)
• Distribution: Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JSO